BEUDAMED
    FDA Recall Terminated

    Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

    Recall: Z-0306-04 · Initiated December 8, 2003

    Recall

    Recall Number
    Z-0306-04
    Event Number
    27927
    Firm
    General Electric Med Systems
    FEI Number
    2126677
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 8, 2003
    Posted
    January 8, 2004
    Terminated
    November 15, 2005
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

    Reason

    Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

    Action

    Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure.

    Distribution

    Distributed nationwide throughout the US and worldwide.

    Quantity

    400